Recruiting

Q Therapeutic

Sponsor:

University of Florida

Code:

NCT07095920

Conditions

Stroke

Chronic Stroke Patients

Cerebrovascular Accident (CVA)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Device: Q Therapeutic System (BQ 3.0) - Active

Study Details

Brief summary:

This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. This trial is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the rehabilitation of people with chronic stroke.

Conditions

Stroke

Chronic Stroke Patients

Cerebrovascular Accident (CVA)

Study ID

NCT07095920

Start date

Aug 27, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
2. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
3. Age 18 to 80 years of age (inclusive).
4. Stroke due to ischemia or to intracerebral hemorrhage.
5. >6 months to 5 years from stroke onset.
6. Box \& Block Test score with affected arm is ≥1 block in 60 seconds.
7. Able to sit with the investigational system for 40 consecutive minutes.
8. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent.
9. Willingness to participate in physical exercises during study intervention sessions.
10. Availability of a relative or other caregiver that is able to participate in training and assist during treatment sessions at Brooks and home during the study duration.
11. If female, not pregnant or breastfeeding or planning pregnancy during the study period.
12. The subject is able to provide Informed consent.

Exclusion Criteria:

1. Severe neglect impairment interfering with assessments or treatments.
2. Severe depression, defined as Geriatric Depression Scale (GDS) Score >10/15
3. Presence of implanted or retained MR-incompatible devices or materials, or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).
4. Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years
5. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
6. Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
7. Pre-existing neurological condition (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
8. Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
9. Unstable serious illness/condition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
10. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
11. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
12. Active participation in an upper extremity rehabilitation program provided by a licensed provider within 4 weeks from the screening visit and until the primary endpoint visit.
13. Employee of the Sponsor.
14. Prisoner.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BQ3.0 Active Stimulation

60 sessions over a period of 12 weeks (5 treatments per week) of active study intervention with the BQ 3.0 (frequency and intensity parameters will be set to 1-100 Hz.; 0.1-1.0 G), including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.

Interventions

Device: Q Therapeutic System (BQ 3.0) - Active

The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.

Primary outcome measure

  • Change in Fugl-Meyer Assessment - Upper Extremity [ Time Frame: Baseline, 3 months after, and 6 months after start of interventions ]
  • Change from Baseline in Modified Rankin Scale (mRS) [ Time Frame: Baseline, 3 months after, and 6 months after the start of interventions ]

Central Contacts and Locations

Central contacts

Emily J Fox, PT, DPT, MHS, PhD

904-742-2500ejfox@phhp.ufl.edu

Jennifer Brooke Hoisington, MSPT

904-659-3733brooke.hoisington@brooksrehab.org

Locations

Brooks Rehabilitation Clinical Research Center

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Jennifer Brooke Hoisington, MSPT

904-659-3733brooke.hoisington@brooksrehab.org

Principal Investigator:

Emily J Fox, PT, DPT, MHS, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

  • BrainQ
  • Electromagnetic Stimulation
  • upper extremity
  • rehabilitation
  • exercise
  • mobility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-02.